Depressive Disorder, Major Clinical Trial
— BIODEPOfficial title:
A Clinical Biomarker Study of Immunological Phenotypes Associated With Monoaminergic Anti-depressant Response, and the Brain and Cognitive Phenotypes Associated With Variation in Peripheral C-reactive Protein (CRP) Levels, in Patients With Major Depressive Disorder (MDD).
NCT number | NCT02752178 |
Other study ID # | 15/EE/0092 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 2015 |
Est. completion date | September 2018 |
Verified date | September 2018 |
Source | University of Cambridge |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This is a study to characterise the role of inflammatory processes in depression. There is compelling evidence that inflammation is often associated with, and can cause, depression. It is currently less clear that antiinflammatory drugs have meaningful antidepressant effect. One of the goals is to identify the subset of depressed patients that is most likely to respond better to an antiinflammatory drug than to a conventional antidepressant. The investigators will therefore undertake a study of patients with a diagnosis of major depressive disorder including four groups: i) incompletely responsive patients who have demonstrated failure to respond consistently or completely to standard treatment, ii) those who have responded well to treatment and are not currently depressed, iii) untreated patients who are currently depressed, iv) healthy volunteers with no history of depression. Participants will undergo a clinical assessment, an interview with a trained member of the research team and will complete self-rated questionnaires. Investigators will collect blood and saliva samples to measure certain immune markers. They will also perform magnetic resonance imaging (MRI) scans to look for MRI markers in the brain and investigate brain inflammation in a subsample of these patients using positron emission topography (PET) and cerebrospinal fluid (CSF) sampling (also called lumbar puncture).
Status | Completed |
Enrollment | 393 |
Est. completion date | September 2018 |
Est. primary completion date | September 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 25 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Major depressive disorder diagnosed by structured clinical interview in accordance with Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria - Aged 25-50 years inclusive - HAM-D score at baseline 1. DEP+MA+ subgroup > 13 2. DEP+MA- subgroup > 17 3. DEP-MA+ subgroup < 7 - Able and willing to give informed consent, including consent to sharing of clinical information with the participant's general practitioner - Willing to abstain from strenuous exercise for 72 hours prior to assessment - Able to write, speak and understand English Exclusion Criteria: - Life time history of bipolar disorder or nonaffective psychosis - Concurrent medication likely to compromise the interpretation of immunological data (including, but not limited to corticosteroids, or any other substance to be determined by the Principal Investigator or delegate) - Pregnancy or breast feeding - Active alcohol or drug abuse or dependence in the last 6 months - Participation in clinical trial of an investigational drug within the last 12 months - Lifetime history of any serious medical disorder likely to compromise the interpretation of immunological data (including, but not limited to, immunological disorders, cardiovascular disorders, malignancies or infection, or any other condition to be determined by the Principal Investigator or delegate) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University of Sussex | Brighton | |
United Kingdom | University of Cambridge | Cambridge | |
United Kingdom | University of Glasgow | Glasgow | |
United Kingdom | King's College London | London | |
United Kingdom | University of Oxford | Oxford |
Lead Sponsor | Collaborator |
---|---|
University of Cambridge | GlaxoSmithKline, H. Lundbeck A/S, Janssen, LP, King's College London, University of Glasgow, University of Oxford, University of Sussex |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | C-reactive protein (CRP) levels (mg/l) | One year after last participant visit | ||
Primary | Flow cytometric immunophenotype | The exact antibody panel will be developed during the research study | One year after last participant visit | |
Secondary | Structural parameters of the brain | Measured using MRI. Specifically: larger grey matter volume loss, quantitative parameters (T1, T2), magnetization transfer, and the microstructure of grey and white matter | One year after last participant visit | |
Secondary | Response to stimulus | Specifically: functional MRI (fMRI) signatures obtained in an emotional face recognition and a reward processing task, respectively. | One year after last participant visit | |
Secondary | Microglial activation in the brain | Measured using Positron Emission Tomography (PET) | One year after last participant visit | |
Secondary | Pro-inflammatory (M1-like) phenotype-producing cytokines, such as interleukin (IL)-1, IL-6, and tumor necrosis factor (TNF)-a circulating in cerebrospinal fluid | One year after last participant visit |
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